Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data
A Study to Evaluate the Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data in Healthcare and Remote Settings
Study objective: The primary objective of the clinical investigation is to evaluate the accuracy of BioStamp nPoint system algorithm measurements.
Study design: A single-site, non-significant risk, open-label, prospective non-randomized clinical investigation designed to validate the accuracy of the various physiological parameters that the Wearable Sensor Patches acquire and the system processes.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ohio
-
Cincinnati、Ohio、アメリカ、45212
- CTI Clinical Research Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male or female volunteers, at least 18 years of age at the time of screening visit;
- Fluent in English;
- The subject is willing to comply with the protocol specified evaluations;
- Subject is willing and cognitively able to sign informed consent
Exclusion Criteria:
- Pregnancy;
- Positive urine drug screen
- History of active (clinically significant) skin disorders;
- History of allergic response to silicones or adhesives;
- Subjects with electronic implants of any kind (e.g. pacemaker)
- History of sleep disorders or self-reported insomnia or other sleep conditions;
- Broken, damaged or irritated skin or rashes near the sensor application sites;
- Subjects that are MC10 employees or shareholders, or a spouse or child of an MC10 employee or shareholder;
- Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
他の:Single Arm
This single arm consists of all subjects which will interact with the device under investigation as well as comparator devices. This includes the Physiological signal monitor intervention, Heart rate and heart rate variability comparison device intervention, Respiration rate comparison device intervention, and Activity classification intervention. |
Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.
FDA cleared reference device that monitors heart rate and heart rate variability in subjects
FDA cleared reference device that monitors respiration rate in subjects
Visual annotation of subject posture and other activities used for reference
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device
時間枠:2 days after informed consent
|
Heart rate as measured by the subject device in beats per minute will be compared to the reference device.
The Mean Absolute Error (MAE) between measurements from each device is presented.
|
2 days after informed consent
|
Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device
時間枠:2 days after informed consent
|
Heart Rate Variability RMSSD is measured by the subject device determined by root mean square of successive differences in neighboring RR intervals and will be compared to the reference device.
The Mean Absolute Error (MAE) between measurements from each device is presented.
|
2 days after informed consent
|
Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device
時間枠:2 days after informed consent
|
HRV Ratio as measured by the subject device determined by low frequency content to high frequency content ratio (HRV Ratio) in beats per minute will be compared to the reference device.
The Mean Absolute Error (MAE) between measurements from each device is presented.
|
2 days after informed consent
|
Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device
時間枠:2 days after informed consent
|
Respiration rate as measured by the subject device in breaths per minute will be compared to the reference device.
The Mean Absolute Error (MAE) between measurements from each device is presented.
|
2 days after informed consent
|
Accuracy of Activity Classification as Compared to Visual Annotation
時間枠:2 days after informed consent
|
The device under test will classify a subjects activity into sleeping, standing, sitting, lying, walking and other activities as the subject performs various predefined activities, which are annotated by an observer.
The device's Activity Classification will be compared to the observer's annotation.
The percentage of correct classifications by the device against indicated visual observation is presented.
The percent correct is not a per subject average, but is the percentage of all activity classifications which were correct when compared to ground truth observation.
|
2 days after informed consent
|
Accuracy of Step Count Compared to an Observer's Manual Count
時間枠:2 days after informed consent
|
The number of steps reported by the device under test during a 6 minute walk test will be compared to an observer's manual count of the number of steps taken.
|
2 days after informed consent
|
Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation
時間枠:2 days after informed consent
|
Sleep onset and wake times as reported by the device under test will be compared to an observer's visual annotation of the sleep onset and wake times.
The Mean Absolute Error (MAE) between times as indicated by the device and observed times is presented.
|
2 days after informed consent
|
Accuracy of Posture Classification as Compared to Visual Annotation
時間枠:2 days after informed consent
|
The device under test will classify a subjects activity into sleep posture, standing posture, and sitting posture as the subject performs various predefined activities, which are annotated by an observer.
The device's Posture Classification will be compared to the observer's annotation.
The percentage of correct classifications by the device against indicated visual observation is presented.
The percent correct is not a per subject average, but is the percentage of all posture classifications which were correct when compared to ground truth observation.
|
2 days after informed consent
|
Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale
時間枠:2 days after informed consent
|
The level of sensor adhesion will be assessed by a 5 point scale (0- sensor is greater than or equal to 90% of sensor adhered, 4-sensor completely detached from subject).
Sensors receiving scores of 0 and 1 will be determined to have acceptable adhesion, while scores of 2, 3, and 4 will be considered unacceptable adhesion.
The percentage of sensors which had acceptable adhesion at sensor removal is presented.
|
2 days after informed consent
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- MC10-PTL-103
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Physiological signal monitorの臨床試験
-
Children's Mercy Hospital Kansas CityGabi SmartCare招待による登録
-
Medtronic Cardiac Rhythm and Heart Failure募集
-
Erasmus Medical Center募集
-
Lady Davis InstituteCarebook Technologies Inc.わからない血管疾患 | コロナウイルス | 呼吸器疾患 | 心臓病
-
Washington University School of MedicineThe Foundation for Barnes-Jewish Hospital完了